AstraZeneca’s Soliris (eculizumab) Receives the NMPA’s Approval for the Treatment of Adults with Refractory Generalised Myasthenia Gravis
Shots:
- The NMPA has approved Soliris for adult patients with gMG who are AChR Ab+. The approval was based on the P-III trial (REGAIN) evaluating Soliris in a ratio (1:1) in 125 patients across North America, South America, the EU & Asia
- The results showed a clinical benefit for patients with anti-AChR Ab+ gMG, improvements during the initial 6mos. duration of the (REGAIN) trial was sustained over a treatment period of ≥130wks. in the long-term OLE trial. The safety & tolerability profiles were consistent throughout the primary treatment period & open-label extension
- Soliris (C5 complement inhibitor) was approved in the US, EU, Japan & China for PNH, aHUS & adults with gMG. The therapy was approved in the US, EU & Japan for adults with NMOSD
Ref: AstraZeneca | Image: AstraZeneca
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
